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Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study.

Publication ,  Journal Article
Afdhal, NH; Bacon, BR; Patel, K; Lawitz, EJ; Gordon, SC; Nelson, DR; Challies, TL; Nasser, I; Garg, J; Wei, L-J; McHutchison, JG
Published in: Clin Gastroenterol Hepatol
April 2015

BACKGROUND & AIMS: Liver biopsy is invasive and associated with complications, sampling errors, and observer variability. Vibration-controlled transient elastography (VCTE) with FibroScan can be used to immediately assess liver stiffness. We aimed to define optimal levels of liver stiffness to identify patients with chronic viral hepatitis and significant fibrosis, advanced fibrosis, or cirrhosis. METHODS: In a prospective, 2-phase study, patients with chronic hepatitis C or B underwent VCTE followed by liver biopsy analysis from January 2005 through May 2008 at 6 centers in the United States. In phase 1 we identified optimal levels of liver stiffness for identification of patients with stage F2-F4 or F4 fibrosis (the development phase, n = 188). In phase 2 we tested these cutoff values in a separate cohort of patients (the validation phase, n = 560). All biopsies were assessed for METAVIR stage by a single pathologist in the phase 1 analysis and by a different pathologist in the phase 2 analysis. Diagnostic performances of VCTE were assessed by area under the receiver operating characteristic curve (AUROC) analyses. RESULTS: In phase 1 of the study, liver stiffness measurements identified patients with ≥ F2 fibrosis with AUROC value of 0.89 (95% confidence interval, 0.83-0.92) and identified patients with F4 fibrosis with AUROC value of 0.92 (95% confidence interval, 0.87-0.95). Liver stiffness cutoff values (kPa) in phase 1 were 8.4 for ≥ F2 (82% sensitivity, 79% specificity) and 12.8 for F4 (84% sensitivity, 86% specificity). In the phase 2 analysis, the liver stiffness cutoff values identified patients with ≥ F2 fibrosis with 58% sensitivity (P < .0001 vs phase 1) and 75% specificity (nonsignificant difference vs phase 1); they identified patients with F4 fibrosis with 76% sensitivity (P < .0001 vs phase 1) and 85% specificity (nonsignificant differences vs phase 1). VCTE had an interobserver agreement correlation coefficient of 0.98 (n = 26) and an intraobserver agreement correlation coefficient of 0.95 (n = 34). CONCLUSIONS: In a large U.S. multicenter study, we confirmed that VCTE provides an accurate assessment of liver fibrosis in patients with chronic viral hepatitis. Our findings are similar to those from European and Asian cohorts.

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Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

April 2015

Volume

13

Issue

4

Start / End Page

772-9.e1-3

Location

United States

Related Subject Headings

  • United States
  • ROC Curve
  • Prospective Studies
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Humans
  • Histocytochemistry
  • Hepatitis C, Chronic
  • Hepatitis B, Chronic
 

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Afdhal, N. H., Bacon, B. R., Patel, K., Lawitz, E. J., Gordon, S. C., Nelson, D. R., … McHutchison, J. G. (2015). Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol, 13(4), 772-9.e1-3. https://doi.org/10.1016/j.cgh.2014.12.014
Afdhal, Nezam H., Bruce R. Bacon, Keyur Patel, Eric J. Lawitz, Stuart C. Gordon, David R. Nelson, Tracy L. Challies, et al. “Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study.Clin Gastroenterol Hepatol 13, no. 4 (April 2015): 772-9.e1-3. https://doi.org/10.1016/j.cgh.2014.12.014.
Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, et al. Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol. 2015 Apr;13(4):772-9.e1-3.
Afdhal, Nezam H., et al. “Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study.Clin Gastroenterol Hepatol, vol. 13, no. 4, Apr. 2015, pp. 772-9.e1-3. Pubmed, doi:10.1016/j.cgh.2014.12.014.
Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, Challies TL, Nasser I, Garg J, Wei L-J, McHutchison JG. Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol. 2015 Apr;13(4):772-9.e1–3.
Journal cover image

Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

April 2015

Volume

13

Issue

4

Start / End Page

772-9.e1-3

Location

United States

Related Subject Headings

  • United States
  • ROC Curve
  • Prospective Studies
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Humans
  • Histocytochemistry
  • Hepatitis C, Chronic
  • Hepatitis B, Chronic